Procedures To Follow During In Process, Off-line and On-line Packing

Below are suggested guidelines for pharmaceutical companies to follow for online and offline packing of products.

  1. Do a line clearance of the packing line as indicated in the SOP and record the results. To do this, check that:
    • All materials from previous operations have been removed
    • Equipment and accessories from previous operations have been removed
    • Paperwork from previous operations has been removed
    • Status labels from previous operation shave been removed
    • All the equipment and accessories required for the packing line are clean and clearly lablelled.
  1. After weighing and entering it in the BMR, transfer the whole batch of product to the stripping or blistering area.
  1. Do a line clearance for the over printing machine as per the SOP.
  2. Do machine line clearance as per the SOP.
  3. Do line clearance for packing conveyor belt as per SOP.
  4. Check and verify the printing details that are printed in aluminium foils, cartons and shipper labels with the QA head.
  5. Do a leak seal test as per SOP and check it hourly; record each hourly result in the BMR.
  6. Check and document the sealing roller temperature, forming plate temperature and temperature and humidity of the machine cubicle on an hourly basis in the BMR.
  7. Choose randomly 5 show boxes, 3 shipper, or 10 bricks for checking purposes, maintaining a record on an hourly basis for each sample, and record in the BMR.
    • Check the show boxes for any dirt, damage, tears or other defects.
    • Check strips for identification, improper sealing, broken tablets, defective printing, missing overprinting of details, and empty pockets.
    • Check the show boxes for any overprinted details.
    • Check the inserts for any missing or wrong inserts.
    • Check the name, address and other details required on the shipper label for any overprints or errors, affix one label on the outside of the box and insert a copy of the same in the box for the shipper.
    • Check the 5ply outer box for any dirt, tears or moisture damage.
  1. If any defects are discovered during the packing process, stop the process and solve the problem. Check the all items packed in the previous hour to make sure that all packed goods are okay.
  1. Resume the processing and perform all the in-process checks after solving the problem.
  2. Arrange the finished items on a pallet for checking and verification by the supervisor.
  3. After packing is complete, reconcile all the packing materials and document all these in the BMR.
  4. Return all the excess unused packing material to stores, as per SOP for return of packing and raw materials:
    • A store person should carry out the reconciliation of returned materials.
    • The store person should compare the weight of material received and the actual consumption. If there is a difference in weight, this needs to be recorded, preferably as a percentage loss.
    • If the variation after reconciliation of active raw material is more than 0.5%, inactive material more than 1%, or volatile solvent more than 2% of the received quantity, further investigation should be instigated by the store personnel.
    • Packing materials returned to stores should not have a variance of more than 1%.
    • If an abnormal loss is recorded, the heads of stores, QA and QC departments should be informed.
  1. Transfer the packed goods to shipping once approval has been granted by the QA department.
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